KCT0000627已完成未知
A randomized, multicenter, open-label study to comparison of tenofovir monotherapy with entecavir-adefovir combination in suboptimal responder for lamivudine plus adefovir rescue therapy in chronic hepatitis B patients with YMDD mutation
Soon Chun Hyang University Hospital Cheonan0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Age, 20 Years to 75 Years
- •2) HBsAg positive at least 6 months or more
- •3) Confirmed emergence of YMDD mutations (rtM204) with/without compensatory mutation (rtL180) with test for mutation profile and with virologic breakthrough (? serum HBV DNA > 1 log IU/mL at any time before screening
- •4) Received ADV-LAM combination therapy at least 24 weeks
- •5) Serum HBV DNA positive in real-time PCR assay despite continued preceding LAM and ADV combination therapy
- •6) Serum HBV DNA >60 IU/mL at screening for this study
排除标准
- •1) Confirmed emergence of such drug resistant mutations (rtI169, rtT184, rtS202, rtM250) at any time before screening
- •2) Patient with decompensated cirrhosis (uncontrolled ascites, history of variceal bleeding, history of hepatic encephalopathy, Child-Pugh score > 8)
- •3) Patient has evidence of renal insufficiency defined as eGFR < 60 ml/min (using the Cockcroft-Gault equation)
- •4) Patient has received interferon or other immunomodulatory treatment for HBV infection in the 6 months before screening for this study.
- •5) Patient has medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agent (including chemotherapeutic agent)
- •6) Patient is currently abusing alcohol (more than 40 g/day in men, 20 g/day in women) or illicit drugs
- •7) Patient has concomitant other chronic viral infection (HCV or HIV)
- •8)Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., autoimmune hepatitis, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
- •9) Patient is pregnant or breastfeeding
- •10) Patient has a history of HCC or findings suggestive of possible HCC, such as suspicious foci on imaging studies. In patients with such findings, HCC should be ruled-out prior to randomizing the patient for the present study.
- •11) A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
- •12) Patient has severe bone disease (osteomalacia, chronic osteomyelitis, osteogenesis imperfect, osteochondroses)
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